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Indications/Uses
Treatment and prevention of Pneumocystis jiroveci (P. carinii) pneumonitis.
Urinary tract infections: Acute uncomplicated urinary tract infections: Treatment of urinary tract infections where there is bacterial evidence of sensitivity to Cotrimoxazole and good reason to prefer this combination to a single antibiotic.
Respiratory tract infections: Otitis media: Acute treatment of otitis media, where there is good reason to prefer Cotrimoxazole to single antibiotic.
Treatment of acute exacerbations of chronic bronchitis, where there is bacterial evidence of sensitivity to Cotrimoxazole and good reason to prefer this combination to a single antibiotic.
Urinary tract infections: Acute uncomplicated urinary tract infections: Treatment of urinary tract infections where there is bacterial evidence of sensitivity to Cotrimoxazole and good reason to prefer this combination to a single antibiotic.
Respiratory tract infections: Otitis media: Acute treatment of otitis media, where there is good reason to prefer Cotrimoxazole to single antibiotic.
Treatment of acute exacerbations of chronic bronchitis, where there is bacterial evidence of sensitivity to Cotrimoxazole and good reason to prefer this combination to a single antibiotic.
Dosage/Direction for Use
Children ages 12 years and below: 6 - 12 years: 1 - 2 teaspoonfuls (5 mL - 10 mL) every 12 hours.
2 - 5 years: 1/2 - 1 teaspoonful (2.5 mL - 5 mL) every 12 hours.
Children under 2 years: 1/2 teaspoonful (2.5 mL) every 12 hours.
Or as prescribed by a physician.
Adults: 2 - 4 teaspoonfuls (10 mL - 20 mL) every 12 hours.
Or as prescribed by a physician.
2 - 5 years: 1/2 - 1 teaspoonful (2.5 mL - 5 mL) every 12 hours.
Children under 2 years: 1/2 teaspoonful (2.5 mL) every 12 hours.
Or as prescribed by a physician.
Adults: 2 - 4 teaspoonfuls (10 mL - 20 mL) every 12 hours.
Or as prescribed by a physician.
Administration
May be taken with or without food.
Contraindications
Cotrimoxazole should not be given to patients with a history of hypersensitivity to sulphonamides and trimethoprim, Cotrimoxazole or any excipients of Cotrimoxazole. Contraindicated in patients showing marked liver parenchymal damage. Contraindicated in severe renal insufficiency where repeated measurement of the plasma concentration cannot be performed. Except under careful supervision, Cotrimoxazole should not be given to patients with serious haematological disorders. Cotrimoxazole has been given to patients receiving cytotoxic therapy with little or no additional effect on the bone marrow or peripheral blood. Cotrimoxazole should not be given to premature babies nor to full-term infants during the first 6 weeks of life except for the treatment/prophylaxis of PCP in infants 4 weeks of age or greater. Fatalities, although very rare, have occurred due to severe reactions including Stevens-Johnson syndrome, Lyell's syndrome (toxic epidermal necrolysis), fulminant hepatic necrosis, agranulocytosis, aplastic anaemia, other blood dyscrasias and hypersensitivity of the respiratory tract. Cotrimoxazole should be discontinued at the first appearance of skin rash.
Special Precautions
Cotrimoxazole should be given with caution to patients with severe allergy or bronchial asthma. Cotrimoxazole should not be used in the treatment of streptococcal pharyngitis due to Group A beta-haemolytic streptococci; eradication of these organisms from the oropharynx is less effective than with penicillin.
Trimethoprim has been noted to impair phenylalanine metabolism but this is of no significance in phenylketonuric patients on appropriate dietary restriction.
Trimethoprim has been noted to impair phenylalanine metabolism but this is of no significance in phenylketonuric patients on appropriate dietary restriction.
Storage
Store at temperatures not exceeding 30°C.
Shake well before using.
Shake well before using.
Action
Pharmacology: Sulfamethoxazole competitively inhibits the utilization of para-aminobenzoic acid in the synthesis of dihydrofolate by the bacterial cell resulting in bacteriostasis. Trimethoprim reversibly inhibits bacterial dihydrofolate reductase (DHFR), an enzyme active in the folate metabolic pathway converting dihydrofolate to tetrahydrofolate. Depending on the conditions, the effect may be bactericidal. Thus trimethoprim and sulfamethoxazole block two consecutive steps in the biosynthesis of purines and therefore nucleic acids essential to many bacteria. This action produces marked potentiation of activity in vitro between the two agents. Trimethoprim binds to plasmodial DHFR but less tightly than to the bacterial enzyme. Its affinity for mammalian DHFR is some 50,000 times less than for the corresponding bacterial enzyme. Many of common pathogenic bacteria are sensitive in vitro to trimethoprim and sulfamethoxazole at concentrations well below those reached in blood, tissue fluids and urine after the administration of recommended doses. In common with other antibiotics, however, in vitro activity does not necessarily imply that clinical efficacy has been demonstrated and it must be noted that satisfactory sensitivity testing is achieved only with recommended media free from inhibitory substances especially thymidine and thymine.
Pharmacokinetics: After oral administration trimethoprim and sulfamethoxazole are rapidly and nearly completely absorbed. The presence of food does not appear to delay absorption. Peak levels in the blood occur between one and four hours after ingestion and the level attained is dose related. Effective levels persist in the blood for up to 24 hours after a therapeutic dose. Steady state levels in adults are reached after dosing for 2 - 3 days. Neither component has an appreciable effect on the concentrations achieved in the blood by the other.
Trimethoprim is a weak base with a pKa of 7.4. It is lipophilic. Tissue levels of trimethoprim are generally higher than corresponding plasma levels, the lungs and kidneys showing especially high concentrations. Trimethoprim concentrations exceed those in plasma in the case of bile, prostatic fluid and tissue, saliva, sputum and vaginal secretions. Levels in the aqueous humor, breast milk, cerebrospinal fluid, middle ear fluid, synovial fluid and tissue (intestinal) fluid are adequate for antibacterial activity. Trimethoprim passes into amniotic fluid and foetal tissues reaching concentrations approximating those of maternal serum.
Approximately 50% of trimethoprim in the plasma is protein bound. The half-life in man is in the range of 8.6 to 17 hours in the presence of normal renal function. It is increased by a factor of 1.5 to 3.0 when the creatinine clearance is less than 10 mL/minute. There appears to be no significant difference in the elderly compared with the young patients. The principal route of excretion of trimethoprim is renal and approximately 50% of the dose is excreted in the urine within 24 hours as unchanged drug. Several metabolites have been identified in the urine. Urinary concentrations of trimethoprim vary widely.
Pharmacokinetics: After oral administration trimethoprim and sulfamethoxazole are rapidly and nearly completely absorbed. The presence of food does not appear to delay absorption. Peak levels in the blood occur between one and four hours after ingestion and the level attained is dose related. Effective levels persist in the blood for up to 24 hours after a therapeutic dose. Steady state levels in adults are reached after dosing for 2 - 3 days. Neither component has an appreciable effect on the concentrations achieved in the blood by the other.
Trimethoprim is a weak base with a pKa of 7.4. It is lipophilic. Tissue levels of trimethoprim are generally higher than corresponding plasma levels, the lungs and kidneys showing especially high concentrations. Trimethoprim concentrations exceed those in plasma in the case of bile, prostatic fluid and tissue, saliva, sputum and vaginal secretions. Levels in the aqueous humor, breast milk, cerebrospinal fluid, middle ear fluid, synovial fluid and tissue (intestinal) fluid are adequate for antibacterial activity. Trimethoprim passes into amniotic fluid and foetal tissues reaching concentrations approximating those of maternal serum.
Approximately 50% of trimethoprim in the plasma is protein bound. The half-life in man is in the range of 8.6 to 17 hours in the presence of normal renal function. It is increased by a factor of 1.5 to 3.0 when the creatinine clearance is less than 10 mL/minute. There appears to be no significant difference in the elderly compared with the young patients. The principal route of excretion of trimethoprim is renal and approximately 50% of the dose is excreted in the urine within 24 hours as unchanged drug. Several metabolites have been identified in the urine. Urinary concentrations of trimethoprim vary widely.
MedsGo Class
Features
Dosage
400 mg / 80 mg per 5 ml
Ingredients
- Cotrimoxazole
Packaging
Suspension 60ml
Generic Name
Cotrimoxazole
Registration Number
DR-XY16961
Classification
Prescription Drug (RX)
Product Questions
Questions
